Hemispherx Biopharma Inc. said Friday it has received a notice from the Food and Drug Administration that the company’s new drug submission for Ampligen, an experimental treatment for chronic fatigue syndrome, was determined to be insufficiently complete.
The Philadelphia biotechnology company said the FDA found 11 deficiencies in the application’s clinical section and three in its pre-clinical section.
Hemispherx (AMEX:HEB – News) officials said part of the problem with its filing may be the clinical data reporting guidelines have changed since the initial studies on Ampligen were executed in the late 1980s and early 1990s.
The company said it plans to respond promptly in writing to all of the filing issues raised by the FDA and will request a guidance meeting to clarify any items outstanding.
Source: Philadelphia Business Journal
Date: December 7, 2007